Clinical Bioequivalence Study on Two Lisinopril Tablets 20mg Formulations

NCT03599466 | Unknown Phase 1 DMC

• 1 other identifier: BABE-P15-099
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the study is to compare the bioavailability of a generic product of lisinopril with that of a reference product when administered to healthy volunteers under fasting condition. The test product is BF-Lisinopril Tablet 20mg (HK-63564) manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Zestril Tab 20mg (HK-30515). The bioequivalence or bioinequivalence of the test and reference formulations will be assessed and concluded based on the plasma pharmacokinetic data of lisinopril, as well as WHO guidelines on registration requirements to establish interchangeability.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Peak plasma concentration (Cmax) of Lisinopril

  Peak drug concentration, obtained directly from the original concentration-time data.

  48 hours

• Area under the plasma concentration versus time curve (AUC) of Lisinopril

  Area under the concentration-time curve from time zero to the last sampling time.

  48 hours

Secondary Outcomes (2)

• Time to maximum concentration (Tmax) of Lisinopril

  48 hours

• Elimination half-life (t1/2) of Lisinopril

  48 hours

Study Arms (2)

BF-Lisinopril Tablets 20mg

EXPERIMENTAL

During the study session, the subjects will be administered a single dose of BF-Lisinopril Tablet 20mg after an overnight fast of approximately 10 hours.

Drug: BF-Lisinopril Tablets 20mg; Drug: Zestril Tab 20mg

Zestril Tab 20mg

ACTIVE COMPARATOR

During the study session, the subjects will be administered a single dose of Zestril Tab 20mg after an overnight fast of approximately 10 hours.

Drug: BF-Lisinopril Tablets 20mg; Drug: Zestril Tab 20mg

Interventions

BF-Lisinopril Tablets 20mg DRUG

BF-Lisinopril Tablets 20mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

BF-Lisinopril Tablets 20mg; Zestril Tab 20mg

Zestril Tab 20mg DRUG

Zestril Tab 20mg will be used as a reference drug in this study

BF-Lisinopril Tablets 20mg; Zestril Tab 20mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and non-pregnant female, 18 to 55 years of age
• Body Mass Index between 18 to 30 kg/m2
• Accessible vein for blood sampling
• High probability for compliance and completion of the study
• Female subjects must agree to practice abstinence or take effective contraceptive methods to prevent pregnancy from the start of the screening and until two weeks of last dose administration.

You may not qualify if:

• Clinically significant hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
• Clinically significant abnormality in physical examination, vital sign, laboratory test results, ECG evaluation, urine test, blood chemistry or haematological test
• Regular consumption of tobacco used in any forms
• Regular consumer of alcohol (more than one drink per day)
• Blood donation within 4 weeks prior to the start of the study
• Use of lisinopril within 4 weeks before the study
• Use of antihypertensive medications or angiotensin-converting enzyme (ACE) inhibitors within 4 weeks before the study
• Volunteer in any other clinical drug study within 2 months prior to this study
• Hypersensitivity to lisinopril or other drugs in its class
• History of drug abuse in any form
• Female subjects who are breastfeeding or pregnant

Sponsors & Collaborators

• Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited: lead
• Chinese University of Hong Kong: collaborator

MeSH Terms

Interventions

Lisinopril

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Zhong Zuo

  School of Pharmacy, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Riza Ozaki

  Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong

  STUDY DIRECTOR

• Brian Tomlinsion

  Department of Medicine and Therapeutics, The Chinese University of Hong Kong

  STUDY DIRECTOR

Central Study Contacts

Evelyn YM Chau

CONTACT

(852) 26323377; chauevelyn@cuhk.edu.hk

Benny SP Fok

CONTACT

(852) 26323377; bfok@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: July 26, 2018
• Study Start: October 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share